(79 days)
Always® are unscented menstrual pads for absorption of menstrual and other vaginal discharge, and for absorption of urine loss associated with light incontinence due to stress-related activities such as laughs, coughs, sneezes and exercise.
The menstrual pad device has 4 primary components, 1) The permeable topsheet allows fluid to pass through into the core; 2) the absorbent core acquires and stores fluid; 3) the impermeable backsheet prevents fluid transfer beyond the core; 4) the attachment adhesive holds the pad in place, The absorbent core is held in place between the topsheet and the backsheet.
The provided text is a 510(k) summary for the Always® unscented menstrual pad, which is a Class I medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and detailed performance studies like those required for higher-risk devices or novel technologies.
Therefore, the information requested in your prompt (acceptance criteria, specific study design details like sample size for test sets, expert involvement, MRMC studies, standalone performance, ground truth establishment, and training set details) is not applicable and not present in this 510(k) summary for a menstrual pad.
Here's why and what information is provided instead:
- Device Type: This is a menstrual pad, classified as a Class I device (unscented menstrual pad, 21 CFR 884.5435). Class I devices are subject to general controls, and typically do not require extensive clinical data to demonstrate effectiveness.
- Regulatory Pathway: A 510(k) submission primarily aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This means it performs as well as or better than the predicate, with the same intended use and similar technological characteristics.
- Focus of the Summary: The summary focuses on:
- Device Description: What the pad is made of (topsheet, absorbent core, backsheet, adhesive).
- Intended Uses: Absorption of menstrual fluid, other vaginal discharge, and light urine loss.
- Technological Characteristics: Designed to acquire and hold fluids similar to the predicate devices.
- Safety Assessment: A battery of in vitro microbiological testing, biocompatibility testing, and extraction testing. The conclusion is that it is "equally as safe an the predicate devices."
- Conclusion: Safe for intended use and substantially equivalent to predicate devices regarding safety and effectiveness.
Specific answers to your requested points based on the provided text:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overarching acceptance criterion is "substantial equivalence" to the predicate devices in terms of "safety and effectiveness."
- Reported Device Performance: The text states, "The device is designed to acquire and hold menstrual fluids or light urine loss similar to the fluid handing capabilities of the predicate devices." No specific quantitative performance metrics (e.g., absorption capacity in grams, leakage rates, etc.) are provided in this summary. The "Safety Assessment" mentions "in vitro microbiological testing, biocompatibility testing and extraction testing," the results of which "support the conclusion that the 510(k) device is equally as safe an the predicate devices."
-
Sample sizes used for the test set and the data provenance:
- Not applicable/not provided. The "safety tests" are mentioned as a "battery of safety tests," but no details on sample sizes or data provenance are given. These are likely laboratory tests rather than human clinical trials.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not provided. This type of device evaluation doesn't typically involve expert consensus on a "ground truth" for performance. Safety tests are usually evaluated against established laboratory standards or predicate device results.
-
Adjudication method for the test set:
- Not applicable/not provided.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical product (menstrual pad), not an AI/imaging device requiring MRMC studies.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
-
The type of ground truth used:
- For safety, the "ground truth" would be established by laboratory testing standards and comparison to the predicate devices' known safety profiles. For "effectiveness," the "ground truth" is that it performs similarly to the predicate devices based on its design and material characteristics. Specific outcome data or pathology are not mentioned.
-
The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable.
In summary, this 510(k) pertains to a low-risk device where the primary evidence for regulatory clearance is demonstrating substantial equivalence through a comparison of technological characteristics and safety data, rather than extensive clinical efficacy studies with detailed performance metrics and expert-adjudicated ground truth.
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Section 5: 510(k) Summary
| Submitted by: | The Procter & Gamble Company6110 Center Hill AvenueCincinnati, OH 45224 | 9-20-07 |
|---|---|---|
| Contact Person: | Lenore Faulhaber, Ph.D., M.B.A.Regulatory Affairs Manager(513) 634-2466 (voice)(513) 634-7364 (FAX) | |
| Date Summary Prepared: | July 2, 2007 | |
| Trade Name: | Always® unscented menstrual pad | |
| Common Name: | Unscented Menstrual Pad | |
| Classification Name: | Unscented Menstrual Pad (21 CFR 884.5435) | |
| Predicate Devices: | Always® ultra thin unscented menstrual padAlways® Curves unscented menstrual pads(K922575/A) |
Device Description: The menstrual pad device has 4 primary components, 1) The permeable topsheet allows fluid to pass through into the core; 2) the absorbent core acquires and stores fluid; 3) the impermeable backsheet prevents fluid transfer beyond the core; 4) the attachment adhesive holds the pad in place, The absorbent core is held in place between the topsheet and the backsheet.
Intended Uses: Always® are unscented menstrual pads for absorption of menstrual fluid and other vaginal discharge, and for absorption of urine loss associated with light incontinence.
Technological Characteristics: The device is designed to acquire and hold menstrual fluids or light urine loss similar to the fluid handing capabilities of the predicate devices.
Safety Assessment: A battery of safety tests was conducted, including in vitro microbiological testing, biocompatibility testing and extraction testing, to evaluate the safety profile of the 510(k) device. The results of these safety tests support the conclusion that the 510(k) device is equally as safe an the predicate devices.
Conclusions: The results of evaluations for this device support the conclusions that it is safe for its intended use and substantially equivalent to the cited predicate devices with regard to safety and effectiveness.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 0 2007
Ms. Lenore Faulhaber, Ph.D.,M.B.A. Regulatory Affairs Manager The Procter & Gamble Company Product Safety & Regulatory Affairs 6110 Center Hill Avenue CINCINNATI OH 45224
Re: K071827
Trade Name: Always® Unscented Menstrual Pads Regulation Number: 21 CFR §886.5435 Regulation Name: unscented menstrual pad Regulatory Class: I Product Code: HHD Dated: July 2, 2007 Received: July 3, 2007
Dear Dr. Faulhaber:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 100 years from 1906-2006. The logo features the letters "FDA" in a bold, stylized font, with the word "Centennial" written below. The logo is surrounded by text that follows the curve of the circle.
Protesting and Promoting Public Health
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
510(k) Number (if known): K071827
Device Name: Always® unscented menstrual pad
Indications for Use:
Always® are unscented menstrual pads for absorption of menstrual and other vaginal discharge, and for absorption of urine loss associated with light incontinence due to stress-related activities such as laughs, coughs, sneezes and exercise.
Prescription Use (Part 21 CFR 801 Supbart D) AND/OR
Over-The-Counter Use X (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hester Renner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K071827
§ 884.5435 Unscented menstrual pad.
(a)
Identification. An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.